OBJECTIVES:

In April 2017, NICE introduced the budget impact (BI) test for technology appraisals (TAs), resulting in delays of up to 3 years in funding for treatments with a BI of over £20 million in 1 of the first 3 years of use. This study aimed to identify whether oncology regimens assessed in the last year would pass the BI test and to understand the potential impact of delays on patient outcomes.

METHODS:

TAs for oncology drugs being launched in the UK with final guidance documentation published between May 2016 and May 2017 were identified. BI data were extracted from the submission documents and the number of oncology regimens with a BI of >£20 million (i.e., those that would fail the BI test) was determined. The number of additional deaths due to delays in funding was estimated from data on survival gains and eligible patient population projections based on market share assumptions.

RESULTS:

Eighteen relevant TAs were identified and routine funding was recommended by NICE for thirteen of these. No BI data were identified for four drugs; of the remaining nine assessments, eight would pass the BI test. Nivolumab combined with ipilimumab for advanced melanoma (TA 400) was estimated to have a BI (based on list prices) of approximately £22 million (2017), increasing to approximately £32 million (2019). Assuming a confidential patient access scheme for ipilimumab would not decrease the BI below £20 million, access to this combination would be delayed. For a delay of 18 months (midpoint of 0–3 years), the impact was estimated to be 206 or 412 additional deaths, assuming uptake of 25% or 50%, respectively.

CONCLUSIONS:

Although the number of oncology treatments affected by the new BI test may be small, the impact of delayed access to potentially cost-effective treatments on patient outcomes may be considerable.